Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine

Generic name: Acetaminophen, Dextromethorphan, Doxylamine, And Pseudoephedrine
Dosage form: oral liquid (1000 mg-30 mg-12.5 mg-60 mg/30 mL)
Drug class: Upper respiratory combinations

Usage of Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the cough reflex in the brain that triggers coughing.

Doxylamine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine is a combination medicine used to treat headache, fever, body aches, cough, runny nose, sneezing, and sinus congestion caused by the common cold, or the flu.

acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine may also be used for purposes not listed in this medication guide.

Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

This medicine may cause serious side effects. Stop using this medicine and call your doctor at once if you have:

pounding heartbeats or fluttering in your chest;

a light-headed feeling, like you might pass out;

anxiety, feeling nervous, trouble sleeping;

little or no urination; or

liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

Common side effects of acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine may include:

drowsiness;

constipation, diarrhea, upset stomach, vomiting; or

feeling restless or excited (especially in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine

You should not use this medicine if you are allergic to acetaminophen, dextromethorphan, doxylamine, or pseudoephedrine.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

a cough with mucus;

liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;

heart disease, high blood pressure;

glaucoma;

diabetes;

a thyroid disorder;

enlarged prostate with urination problems; or

if you take a blood thinner such as warfarin (Coumadin, Jantoven).

It is not known whether this medication will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

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How to use Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine

Usual Adult Dose for Cold Symptoms:

acetaminophen/dextromethorphan/doxylamine/PSE 325 mg-15 mg-6.25 mg-30 mg oral capsule: 1 to 2 capsules orally every 6 hours not to exceed 8 capsules daily.

Usual Pediatric Dose for Cold Symptoms:

acetaminophen/dextromethorphan/doxylamine/PSE 325 mg-15 mg-6.25 mg-30 mg oral capsule: 12 yrs and older: 1 to 2 capsules orally every 6 hours not to exceed 8 capsules daily.

Warnings

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

What other drugs will affect Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

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